SUPPLIER QUALITY SYSTEM AUDIT CHECKLIST PAGE: 1 of 9

Supplier Name:

Address:

City: State: Zip Code:

Country:

Phone: Fax:

Parent Company:

President: Phone:

VP Operation: Phone:

QA/QC Manager: Phone:

Sales Contact: Phone:

Completed By:

(Name) (Title) (Date)

EPM Flow Group USE ONLY
Audit Date: Audit Location:
Audit Scope: New Supplier Approval Maintenance Evaluation (Surveillance Audit)
Lead Auditor / Title:
Auditee Personnel:

Audit Results: No. of Findings: Corrective Actions Request Issued: Yes No
Scheduled Corrective Action Completion Date:
General Remarks (if any):

Audit Disposition: Approved Disapproved
Conditionally Approved (comments):

Signature / Date:
Lead Auditor Procurement (Review) Director of Quality (Approval)

Form B (Rev 1)

SUPPLIER QUALITY SYSTEM AUDIT CHECKLIST PAGE: 2 of 9

Item / Requirement / Yes / No / N/A / Comments

Section 1 – QUALITY MANAGEMENT SYSTEM

1.1 / Does your organization have process flow map, organizational chart, or another way of showing responsibilities for your process?
1.2 / Does your organization have a quality manual? Are quality policy and objectives defined in the manual?
1.3 / Does your organization have documented procedures to ensure the control of your processes?
1.4 / Is the quality system and documented procedures effectively implemented?
Section 2 – MANAGEMENT RESPONSIBILITY
2.1 / Is the responsibility, and authority of all personnel within the organization who manage, perform and verify work, affecting quality defined and documented?
2.2 / Does top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction?
2.3 / Does your organization take measures to continually improve your processes?
2.4 / Does top management review the quality management system at planned interval to ensure its continuing adequacy and effectiveness?
2.5 / Do inputs to management reviews include audit results, customer feedback, process performance, product conformity, status of preventative and corrective actions, etc?
2.6 / Do the outputs from the management review include any decisions and actions related to improvement of the effectiveness of the quality system and its processes, product related to customer requirements, or resource needs?
2.7 / Are records from management review maintained?
2.8 / Does your organization communicate throughout the company the effectiveness of the quality of your product?

Section 3 – RESOURCE MANAGEMENT

3.1 / Does your organization ensure that personnel directly involved with the quality of your product are competent on the basis of appropriate education, training, skills and experience?
3.2 / Does your organization maintain appropriate records of education, training, skills and experience of your employees directly responsible for the quality of your products?
3.3 / Does your organization provide and maintain the equipment, services, and environment as needed to achieve conformity to product requirements?

Section 4 – CONTRACT REVIEW:

4.1 / Is the contract or order reviewed, prior to its acceptance, to ensure that the requirements are adequately defined and company has the capability to meet contract or order requirements?
4.2 / Does your organization ensure that any amendment to a contract is made and correctly transferred to the concerned functions within the organization?
4.3 / Are contract review records maintained?
Section 5 – Drawing and Specification Control:
5.1 / Does the supplier have a system and documented procedures for controlling the customer drawings and making them available for all operations where operations are performed?
5.2 / Does the system prevent the use of marked, illegible, or obsolete drawings, which are not formally approved or controlled?
Section 6 – Purchasing:
6.1 / Is there a system for qualifying subcontractors?
6.2 / Are documented procedures established and maintained to ensure that purchased product conforms to specified requirements?
6.3 / Are subcontractors evaluated and selected based on their ability to meet quality requirements?
6.4 / Are subcontractor’s quality evaluation records maintained?
Section 7 – Control of Customer Supplied Products:
7.1 / Are documented procedures established and maintained for the control, storage, and maintenance of customer supplied products or gages?
7.2 / Are customer-supplied products or gages that are lost, damaged or otherwise unsuitable for use recorded and reported to the customer?
Section 8 – Product Identification and TracEAbility:
8.1 / Where appropriate, are documented procedures established and maintained for identifying products by suitable means from receipt, during all stages of production, delivery and installation?
8.2 / Where traceability is a specified requirement, are documented procedures established and maintained for uniquely identifying individual products or batches?
Section 9 – Process controls:
9.1 / Are production, installation and servicing processes, which directly affect quality, identified and carried out under controlled conditions?
9.2 / Do qualified operators carry out special processes?
9.3 / Are special process parameters continuously controlled to ensure that the specified requirements are met?
9.4 / Are qualification requirements for process operations, equipment and personnel specified? Are records maintained for this activity?
Section 10 – inspection and testing:
10.1 / Are there methods in place to ensure that incoming products are not used or processed until inspected or verified as conforming to specified requirements?
10.2 / Are in-process products inspected and verified in accordance with the quality plan or documented procedures?
10.3 / Are all final inspections and testing performed in accordance with the quality plan and/or documented procedures?
10.4 / Are records established and maintained which provide evidence that products have passed inspection and/or tests, with defined acceptance criteria?
10.5 / Is product identified as to its status, with regards to the inspection and tests performed by markings, authorized stamps, tags, labels, routing cards, inspection records, test software, physical location, or other suitable means?
Section 11 – statistical techniques:
11.1 / Are statistical techniques required for verifying the acceptability of process capability and product characteristics identified and carried out?
11.2 / Are employees trained on SPC techniques?
11.3 / Is there evidence of capable and stable process?
11.4 / Is there evidence of adequate charting techniques?
Section 12 – control of inspection, measuring and test equipment:
12.1 / Are documented procedures established and maintained to control, calibrate and inspect, measuring and test equipment used to demonstrate product conformance to specified requirements?
12.2 / Is all inspection, measuring and test equipment that can affect quality identified, calibrated and adjusted at prescribed intervals or prior to use?
12.3 / Is all inspection, measuring and test equipment identified with a suitable indicator or approved identification record to show the calibration status?
12.4 / Are calibration records maintained?
12.5 / Where inspection, measuring and test equipment has been found to be out of calibration, is the validity of previous inspection and test results assessed and documented?
Section 13 – control of non-conforming products:
13.1 / Are documented procedures established and maintained to ensure that product not conforming to specified requirements, is prevented from unintended use or installation?
13.2 / Does the established method for controlling nonconformance address identification, documentation, evaluation, segregation, disposition and notification to the functions concerned?
13.3 / Is it clearly understood that the proposed use or repair of product, which does not conform to specified requirements, shall be reported to EPM Flow Group for waiver?
13.4 / Are repaired and reworked products re-inspected in accordance with the quality plan and/or documented procedures?
Section 14 – corrective and preventative actions:
14.1 / Are documented procedures established and maintained for implementing corrective and preventative actions?
14.2 / Does your organization maintain records of actions taken as a result of corrective and preventative actions?
Section 15 – control of quality records:
15.1 / Are the quality records maintained to demonstrate conformance to specified requirements and the effective operation of the quality system?
15.2 / Are the retention times of quality records established and recorded?
Section 16 – internal quality audits:
16.1 / Are documented procedures established and maintained for planning and implementing internal quality audits?
16.2 / Does the management responsible for the relevant area take the timely corrective actions on the deficiencies found during the audit?
16.3 / Do follow-up audit activities verify and record the implementation and effectiveness of the corrective actions taken?
Section 17 – servicing:
17.1 / Where servicing is a specified requirement, are documented procedures established and maintained for performing, verifying and reporting that servicing meets the specified requirements?
Section 18 – handling, storage, packaging, preservation and delivery:
18.1 / Are documented procedures established and maintained for handling, storage, packaging, preservation and delivery of products?
18.2 / Are storage areas or stock rooms designated to prevent damage or deterioration of product, pending in-process use or delivery?
18.3 / Are packaging and marking processes controlled to the extent necessary to ensure conformance to specified requirements?

Form B (Rev 1)

SUPPLIER QUALITY SYSTEM AUDIT CHECKLIST PAGE: 8 of 9

General Comments or Notes:
Audit Findings:
Scheduled Action Completion Date:

Auditee Signature: Date:

Form B (Rev 1)